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Stryker / Mobius Imaging Clinical Regulatory Specialist (Remote) in Shirley, Massachusetts

Who we want Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate. Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Collaborative partners. People who build and leverage cross-functional relationships to bring ideas, data and insights to drive continuous improvement in functions. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. What you will do As a Clinical Regulatory Specialist, you oversee the completion of Clinical Evaluation Reports (CERs) and address Regulatory Body questions requiring clinical data support. You lead Medical Affairs efforts in the development and execution of strategies to obtain information and support concerning medical devices undergoing clinical investigation, post market surveillance or marketed/product use evaluation. This includes activities such as generating clinical plans for New Product Development, fulfilling reporting requirements for FDA clearance/approvals and CE Marking and reviewing and approving collateral material containing clinical data. These activities will facilitate worldwide registration and introduction of new products and provide clinical data and publications of market support and reimbursement of approved devices. You serve as an active member of hub and spoke teams to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global Quality Management Systems. Responsibilities may include but are not limited to: Divisional Process Owner (DPO) for Medical Affairs procedures including authoring and revising standard operating procedures (SOPs) to meet all corporate and regulatory requirements. You are accountable for representing procedures in internal and external audits, responding to and revising procedures according to any findings and overseeing the documents of external origin process. Create and manage detailed project schedule for Clinical Evaluation and Post Market Clinical Follow-Up processes Follow up (PMCF) plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents Facilitate project plan input, review audit study data or reports, prepare clinical sections of US or EU regulatory documentation Collaborate with Regulatory Affairs in submission of IDEs, pre-market approval applications, amendments, supplements, and other regulatory submissions regarding clinical issues Participate as the clinical representative on product development teams, including generation of the clinical plan Represent the clinical team cross-functionally for activities including change control, risk management, and collateral review Oversee and guide Clinical Study Managers in the preparation and development of study protocols and data collection strategies to aid regulatory commitments and marketing claims; make recommendations for statistical analyses Oversee or prepare annual study progress reports and final reports, to include clinical and radiographic data, for regulatory agencies, Investigators and IRBs/ECs Act as liaison with company business units to identify strategies to bring new products to market which require or would benefit from clinical trial data Analyze clinical trial data throughout the study as it relates to pre-market or PMCF requirements; make recommendations for any modifications to the plans or protocols Participate in preparation of clinical research operating plans and objectives, maintaining alignment with company and departmental strategies What you need Bachelor's degree required Minimum 4 years of professional experience preferably as a Clinical Research Associate, Clinical Project Manager or equivalent position supporting Clinical or Medical A

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